Spine BioPharma Completes Enrollment for SB-01 Phase 3 Trial for Chronic Low Back Pain

Spine BioPharma, Inc., a company focused on developing non-opiate, non-surgical treatments for Degenerative Disc Disease (DDD), has completed the enrollment for its U.S. Phase 3 clinical trial of SB-01 For Injection (SB-01). This trial, known as the MODEL trial (Moderate – Severe Degenerative Disc Disease Evaluation of the Lumbar Spine), has enrolled 417 patients at 30 investigational sites across the United States over a period of two years. SB-01 is the first pharmacologic treatment administered directly into the disc to enter Phase 3 trials for chronic low back pain (CLBP) associated with DDD.

Marc Viscogliosi, CEO of Spine BioPharma, highlighted the significance of this milestone for patients, physicians, and the company. He noted that patients who suffer from DDD often have to resort to surgery after exhausting conservative treatment options, which is usually expensive, involves long recovery times, and has unpredictable outcomes. He expressed satisfaction in completing the SB-01 MODEL trial enrollment ahead of schedule, emphasizing that SB-01 could potentially meet the unmet needs of millions of patients suffering from CLBP due to DDD.

Fran Magee, DVM, Chief Technology Officer of Spine BioPharma, extended gratitude to the patients, clinical trial site staff, physicians, and vendor partners who participated in this landmark trial. Magee expressed optimism that the data collected during the trial could provide valuable insights into treatment challenges and potentially offer a new therapeutic option for DDD patients.

DDD affects approximately 266 million people worldwide, with 22.5 million Americans diagnosed each year. Current treatment options for DDD focus on symptom management, utilizing physical therapy, chiropractic care, NSAIDs, or prescription opioids. For severe cases, treatment options include epidural steroid injections, nerve blocks, radiofrequency ablation, or surgery, though outcomes can be variable and unpredictable. CLBP is the second leading cause of chronic opioid use, which poses significant risks of addiction and other serious side effects.

The SB-01 MODEL clinical trial is a U.S.-based, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial designed to assess the safety and efficacy of SB-01 For Injection in adult patients with CLBP and associated functional impairments due to Lumbar DDD.

SB-01 is a synthetic peptide composed of seven amino acids that binds to and inhibits the activity of TGF-Beta, a pleiotropic cytokine present in almost every tissue and cell type. TGF-Beta is abundant in the extracellular matrix and has both suppressive and stimulatory signaling pathways. Elevated concentrations of TGF-Beta in various diseases can lead to negative downstream effects such as inflammation, fibrosis, neoinnervation, nerve hyperexcitability, and cell proliferation. SB-01 modulates TGF-Beta levels to mitigate these negative effects without completely eliminating the cytokine.

Spine BioPharma is dedicated to creating non-opiate, non-surgical treatments aimed at reducing pain, restoring function, and slowing or halting the progression of pathological diseases. The company's lead candidate, SB-01 For Injection, represents a first-in-class treatment for DDD, offering potential clinical benefits that include pain relief, functional restoration, and disease progression prevention.